Hello,

The en556 sets the limits for the quantity of micro-organisms, which can be found on a sterile medical device. The bioburden, before sterilization, has got to meet particular requirements, so that with sterilization it will be possible to reach the limit set by en556. Since the microbiology lab provides data which refer to ufc/cmq, do i have to calculate all the cmq on my medical device (towels and coats used in the operating theatre) or is the data provided by the lab enough to determine a successful sterilization cycle? Are there given parameters regarding bioburden's UFC/cmq in case of items which have to be sterilized?

Alberto Franceschini
Ferrara

Dear,

I think the definition of bioburden given in EN 556 makes it clear:
"Bioburden: Population of viable micro-organisms on a product and/or package."
So you have to take into account the whole surface of the medical device and/or package. It is obvious that the bioburden level should be as low as possible. I am not aware of parameters regarding to bioburden levels. EN 1174 Sterilization of medical devices - Estimation of the population of micro-organisms on product also can give you more information.

Good luck,
Wim Renders